Whitepapers2019-04-19T21:00:41+00:00

Enabling Data Visibility in Contract Manufacturing Networks

October 23rd, 2019|Tags: , , , , , , |

Life Science manufacturing data management has become increasingly difficult with advancements in complex biotech and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging those in other pharma operations, there’s [...]

Economic and Operational Advantages of Skyland PIMS® Cloud-based Data Collaboration Platform for Life Science Manufacturing

September 30th, 2019|Tags: , , , , , , |

Most organizations realize the “true cost” of any business investment is not the initial purchase price, but the Total Cost of Ownership (TCO). TCO measures initial costs plus ongoing costs including those that [...]

Skyland PIMS®: The Industry Standard for Managing and Sharing Process and Product Data with Sponsors

September 30th, 2019|Tags: , , , , , , |

For CDMOs, traditional challenges like capacity, margins, yield and capital requirements have been supplemented by new challenges. The growth in complex products such as biologics, cell and gene therapy and precision medicine has [...]

Smarter Manufacturing Data Management – Using Software Systems to Drive a Successful CPV Program

March 27th, 2019|Tags: , , , , , , |

Overview Data is prevalent through all functions of the Life Science industry. Its value impacts many disciplines throughout an organization, and while the use of data by discipline varies, it always involves: Gathering [...]

Unlocking the Value of Manufacturing Data at a CDMO

March 3rd, 2019|Tags: , , , , , , , |

65% of the FDA’s 2017 warning letters cited data integrityConsequently, this has put pressure on drug sponsors and their CDMOs to implement compliant data management systems that provide transparency, preserve customer confidentiality and meet regulatory [...]